Lupin’s arm receives USFDA approval for generic Zithromax Oral Suspension

Gavis Pharmaceuticals LLC., USA, wholly owned subsidiary of Lupin, has received  tentative approval from the United States Food and Drug Administration (USFDA) for its Azithromycin for oral suspension USP, 300 mg (100 mg/5 mL) and 1200 mg (200 mg/5 mL) to market a generic version of Pfizer Inc.'s Zithromax for oral suspension, 100 mg/5ml and 200 mg/5ml. Lupin had earlier received final approval for its Azithromycin Tablets, 250 mg, 500 mg, 600 mg and Azithromycin for Oral Suspension USP, 100 mg/5 mL and 200 mg/5 mL from the USFDA which was filed from its Goa plant. Zithromax Oral Suspension had US sales of $110.6 million as per IMS MAT June 2016.

Lupin is a pharmaceutical company and is engaged in formulation of drugs and active pharmaceutical ingredients (APIs), generics, biotechnology, novel drug discovery and development, drug delivery systems and specialty pharmaceuticals. The firm offers products in various therapeutic areas such as anti-tuberculosis, cephalosporins, cardiovascular, anti-asthma, anti-infectives, pain reliever, diabetes, pediatrics, gynecology and non-steroidal anti-inflammatory drugs as well as ace inhibitors, statins and prils.